Clinical Research Coordinator I - SPA

• Support participant screening, eligibility verification, and enrollment activities in accordance with study protocol requirements.
• Coordinate and manage participant visits, including admission, scheduling, confinement logistics, and follow-up activities.
• Ensure accurate execution and timing of protocol-required procedures, including pharmacokinetic (PK), pharmacodynamic (PD), and safety assessments.
• Coordinate and monitor collection of protocol-specific study samples, including timed blood draws and specimen tracking.
• Conduct and document safety assessments, including vital signs, pulse oximetry, adverse event collection, concomitant medication review, and participant monitoring.
• Administer and support study-related assessments and questionnaires, including sedation, dissociation, euphoria, and thermal stimulation evaluations.
• Maintain complete and accurate source documentation and case report forms (CRFs) in compliance with study and regulatory requirements.
• Monitor visit flow and protocol adherence to ensure timely completion of study procedures and prevent protocol deviations.
• Perform participant follow-up activities and communicate study-related concerns to the clinical and research team.
• Support overall study coordination activities to ensure quality, regulatory compliance, and successful study execution.
• Adheres to legal, professional and ethical codes with respect to confidentiality and privacy. Assures that protocol requirements are achieved within Good Clinical Practices.
• May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Join the HJF Team!

HJF is seeking a Clinical Research Coordinator I to perform clinical research and patient treatment in conjunction with one or more specified clinical research protocols. Developing adherence to legal, professional and ethical codes with respect to confidentiality and privacy. Helps assure that protocol requirements are achieved within Good Clinical Practices.

This position will be in support of USU Department of Medicine Translational Medicine Unit, located in Bethesda MD. This Phase I study conducted at the Uniformed Services University Translational Medicine Unit, is a randomized, placebo-controlled, double-blind, 4-period crossover study comparing LT-120, an intranasal esketamine nasal spray, with intravenous racemic ketamine under fasted conditions. The primary goal is to compare the bioavailability of intranasal esketamine with IV ketamine, while the secondary goal is to assess the relative analgesic, or antinociceptive, effects of LT-120 using thermal pain testing.

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.